FDA WARNING_LETTER - Freeman and Biddy, LLC d/b/a Freedom Vapes - May 26, 2022

On May 26, 2022, the FDA issued a Warning Letter to Freeman and Biddy, LLC d/b/a Freedom Vapes, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that Freedom Vapes' e-liquid products, specifically "Freedom Vapes Andy’s Mint e-liquid," are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is that these e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and are being sold without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also cited as a prohibited act under section 301(p).

The FDA emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company, a registered manufacturer with over 150 listed products, is required